Lung Ultrasound for the Postoperative Diagnosis of Pneumothorax in Children

NCT ID: NCT03073616

Last Updated: 2019-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will be conducted to determine the advantages and limitations of sonography compared with chest radiography, in the detection of post procedure iatrogenic pneumothorax in patients underwent to Pectus Excavatum (PE) with Nuss repair.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The Nuss procedure is a minimally invasive technique for the repair of Pectus Excavatum (MIRPE).

Residual pneumothorax (PNX) is reported in more than 50% after Nuss procedure. It is a consequence of the introduction of the scope and bar in the pleural space and is considered a minor complication due to the minimal clinical consequences. It is routine practice to confirm the diagnosis of PNX with a conventional chest X-Ray either in the operating room at the end of thoracic surgery or in the recovery room unit immediately after surgery.However, anterior pneumothorax can occur and chest-X ray could not be able to detected the PNX. Nowadays lung ultrasound (LUS) allows a bedside non-invasive evaluation of the patient(with a sensitivity and specificity of 92 and 99% respectively) without exposure to ionized radiation, can be performed more quickly than chest radiography and therefore can be repeated several times without additional risks. The use of LUS in pediatric age groups is more recent, but is becoming widely utilized both in neonatal and pediatric respiratory diseases.

Bedside sonography for diagnosis of PNX has been well described in emergency and trauma medicine literature and it is resulted to be more sensitive and specific than portable anteroposterior chest radiography. Although there are few studies describing the use of ultrasound for the detection of surgical pneumothorax, none of them studied its use after Nuss Procedure.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pectus Excavatum

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lung ultrasound

Every patient will receive a chest RX and lung US

Lung ultrasound

Intervention Type DEVICE

Lung ultrasound and chest RX

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lung ultrasound

Lung ultrasound and chest RX

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients following Nuss procedure for PE repair at Giannina Gaslini Institute

Exclusion Criteria

* absence of informed consent from parents
* poor quality of the pre-operatory acoustic window
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nicola Disma, MD

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nicola Disma, MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istituto Giannina Gaslini

Genova, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Lung-US in children

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.